ASAHI PTCA GUIDE WIRE
FDA 510(k) clearance K070945 · decided 2008-01-09
Clearance details
- K-number
- K070945
- Device name
- ASAHI PTCA GUIDE WIRE
- Applicant
- Asahi Intecc Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2007-04-04
- Decision date
- 2008-01-09
- Days to decision
- 280 days
- Clearance type
- Special
- Product code
- DQX
- Device class
- 2
- Regulation number
- 870.1330
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Santa Ana, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.